510(k) Report

Devices descending from K061202

547 later devices reach Revere Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+1K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+1K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+1K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+1K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+1K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+1K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+1K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+1K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+1K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+1K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+1K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+1K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+1K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+1K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+1K111479Revere CrosstopGlobus Medical, Inc.2011232—
+1K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+1K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+1K100788Cocr RodsGlobus Medical, Inc.2010374—
+1K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+1K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+1K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+1K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+1K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+1K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+1K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+1K073517H-Link Integrated RodGlobus Medical, Inc.20080—
+1K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+1K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+1K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+2K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+2K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+2K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+2K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+2K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+2K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+2K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+2K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+2K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+2K173508Everest Spinal SystemK2m20189—
+2K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+2K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+2K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K142699LITe Plate SystemStryker Corporation201446—
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+2K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+2K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132361Everest Spinal SystemK2m, Inc.201334—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+2K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+2K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+2K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—
+2K080767Conquest Spinal SystemLife Spine200821—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—